Fluid delivery apparatus with flow indicator and vial fill

ABSTRACT

An apparatus for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus is of a compact, low profile, laminate construction and includes an elastic distendable membrane, chamber having a fluid outlet. Disposed within the fluid chamber is a thin fluid permeable member which precisely controls the rate of fluid flow through the fluid outlet. The apparatus also includes a highly novel fluid flow indicator that provides a readily discernible visible indication of fluid flow through the apparatus. Additionally, the apparatus includes a fill assembly comprising a prefilled vial that can be used to fill the fluid reservoir of the device with a selected medicinal fluid.

[0001] This is a Divisional Application of co-pending U.S. applicationSer. No. 09/139,605, filed Aug. 24, 1998; which is a DivisionalApplication of U.S. Ser. No. 08/768,663 filed Dec. 18, 1996 now U.S.Pat. No. 5,849,071.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates generally to fluid deliverydevices. More particularly, the invention concerns an improved apparatusfor infusing medicinal agents into an ambulatory patient at specificvisual rates over extended periods of time, which apparatus includesboth flow indicator means and a novel vial assembly fill means forfilling the reservoir of the device.

[0004] 2. Discussion of the Invention

[0005] Many medicinal agents require an intravenous route foradministration thus bypassing the digestive system and precludingdegradation by the catalytic enzymes in the digestive tract and theliver. The use of more potent medications at elevated concentrations hasalso increased the need for accuracy in controlling the delivery of suchdrugs. The delivery device, while not an active pharmacologic agent, mayenhance the activity of the drug by mediating its therapeuticeffectiveness. Certain classes of new pharmacologic agents possess avery narrow range of therapeutic effectiveness, for instance, too smalla dose results in no effect, while too great a dose results in toxicreaction.

[0006] In the past, prolonged infusion of fluids has generally beenaccomplished using gravity flow methods, which typically involve the useof intravenous administration sets and the familiar bottle suspendedabove the patient. Such methods are cumbersome, imprecise and requirebed confinement of the patient. Periodic monitoring of the apparatus bythe nurse or doctor is required to detect malfunctions of the infusionapparatus.

[0007] Devices from which liquid is expelled from a relativelythick-walled bladder by internal stresses within the distended bladderare well-known in the prior art. Such bladder, or “balloon” type,devices are described in U.S. Pat. No. 3,469,578, issued to Bierman andin U.S. Pat. No. 4,318,400, issued to Perry. The devices of theaforementioned patents also disclose the use of fluid flow restrictorsexternal of the bladder for regulating the rate of fluid flow from thebladder.

[0008] The prior art bladder type infusion devices are not withoutdrawbacks. Generally, because of the very nature of the bladder or“balloon” configuration, the devices are unwieldy and are difficult andexpensive to manufacture and use. Further, the devices are somewhatunreliable and their fluid discharge rates are frequently imprecise.

[0009] The apparatus of the present invention overcomes many of thedrawbacks of the prior art by eliminating the bladder and making use ofrecently developed elastomeric films and similar materials, which, incooperation with a base define a fluid chamber that contains the fluidwhich is to be dispensed. The elastomeric film membrane controllablyforces fluid within the chamber into fluid flow channels provided in thebase.

[0010] The elastomeric film materials used in the apparatus of thepresent invention, as well as various alternate constructions of theapparatus, are described in detail in U.S. Pat. No. 5,205,820 issued tothe present inventor. Therefore, U.S. Pat. No. 5,205,820 is herebyincorporated by reference in its entirety as though fully set forthherein. Co-pending U.S. Ser. No. 08/046,438 filed by the presentinventor on May 18, 1993 also describes various alternate constructionsand modified physical embodiments of the invention. This co-pendingapplication is also hereby incorporated by reference in its entirety asthough fully set forth herein. Because the present application disclosesa novel improvement to the apparatus described in co-pending U.S. Ser.No. 08/432,221 filed May 1, 1995, this co-pending application is alsohereby incorporated by reference in its entirety as though fully setforth herein.

[0011] The apparatus of the present invention can be used with minimalprofessional assistance in an alternate health care environment, such asthe home. By way of example, devices of the invention can be comfortablyand conveniently removably affixed to the patient's body and can be usedfor the continuous infusion of antibiotics, hormones, steroids, bloodclotting agents, analgesics, and like medicinal agents. Similarly, thedevices can be used for I-V chemotherapy and can accurately deliverfluids to the patient in precisely the correct quantities and atextended microfusion rates over time.

[0012] The embodiments of the invention described in Ser. No.08/432,221, which application is incorporated herein by reference,comprises a fluid delivery apparatus having a fluid reservoir, fluidflow control assembly, and an indicator assembly for indicating fluidflow through the apparatus. However, unlike the apparatus of the presentinvention, which includes a unique vial fill assembly for filling thereservoir, the reservoir of the apparatus described in Ser. No.08/432,221 is filled from an external fluid source which is connected toa conventional luer connector provided on the base of the device. Aswill be better understood from the description which follows, the novelvial fill assembly of the present invention significantly expands thecapability of the apparatus, including enabling the reservoir of thedevice to be filled at time of usability to controllably fill thereservoir of the device with a wide variety of medicinal fluids that canbe conveniently stored within the prefilled vial component of the vialassembly.

SUMMARY OF THE INVENTION

[0013] It is an object of the present invention to provide an apparatusfor expelling fluids at a precisely controlled rate which is of acompact, low profile, laminate construction. More particularly, it is anobject of the invention to provide such an apparatus which can be usedfor the precise infusion of pharmaceutical fluids to an ambulatorypatient at controlled rates over extended periods of time.

[0014] It is another object of the invention to provide an apparatus ofthe aforementioned character which is highly reliable and easy-to-use bylay persons in a non-hospital environment.

[0015] Another object of the invention is to provide an apparatus whichcan be factory prefilled with a wide variety of medicinal fluids or onewhich can readily be filled in the field shortly prior to use.

[0016] A further object of the invention is to provide a low profile,fluid delivery device of laminate construction which can be manufacturedinexpensively in large volume by automated machinery.

[0017] Another object of the invention is to provide a device of theaforementioned character which includes a novel rate control membranedisposed intermediate the fluid reservoir outlet and the outlet port ofthe device.

[0018] Another object of the invention is to provide a device of thecharacter described which embodies a highly novel fluid flow indicatorthat provides a readily discernible visual indication of fluid flowstatus through the device.

[0019] Another object of the invention is to provide an apparatus of theaforementioned character in which the stored energy source is of a novellaminate construction which can be precisely tailored to deliver fluidfrom the device at precise rates.

[0020] Another object of the invention is to provide a unique fillassembly for use in controllably filling the fluid reservoir of theapparatus.

[0021] Another object of the present invention is to provide anapparatus of the aforementioned character in which the fill assemblycomprises a vial assembly that can be prefilled with a wide variety ofmedicinal fluids.

[0022] Another object of the present invention is to provide a fillassembly of the type described in the preceding paragraph in which theprefilled vial assembly is partially received within the housing of thefluid dispensing device for operable interconnection therewith.

[0023] Another object of the invention is to provide an apparatus asdescribed in the preceding paragraphs which includes locking means forlocking the vial assembly to the fluid delivery assembly followingfilling of the fluid reservoir.

[0024] Another object of the invention is to provide a novel vialassembly for use with the fluid dispenser subassembly of the apparatuswhich is easy to use, is inexpensive to manufacture, and one whichmaintains the vial in an aseptic condition until time of use.

[0025] Other objects of the invention are set forth in U.S. Pat. No.5,205,820 which is incorporated herein and still further objects willbecome more apparent from the discussion which follows.

[0026] By way of summary, the improved fluid delivery apparatus of thepresent form of the invention comprises four cooperating subassemblies,namely a reservoir assembly, a fluid flow control subassembly, a flowindicator subassembly and a reservoir fill assembly. The reservoirsubassembly, which readily lends itself to automated manufacture, isgenerally similar to that described in copending Ser. No. 08/432,221 andincludes a base and a stored energy means comprising at least onedistendable elastomeric membrane which cooperates with the base to forma fluid reservoir. The fluid flow control subassembly is also similar tothat described in Ser. No. 08/432,221 in that it comprises a thinpermeable flow control membrane which controls the rate of flow of fluidflowing toward the outlet port of the device.

[0027] As will be discussed in greater detail hereinafter, the highlynovel fluid flow indicator means of the invention comprises a mechanicalfluid flow indicator that provides a clear visual indication of normalfluid flow and absence of fluid flow either because the reservoir isempty or because the flow lines are occluded. More particularly, symbolsindicating the operating condition of the device are produced by themovement of thin, indicia-carrying films. These films, which comprise apart of the flow indicator means, are shifted by the movement ofmechanical actuators which are deflected solely by the fluid pressurewithin the device. The fluid flow indicator design does not invade thefluid flow path and yet utilizes the same stored energy means togenerate fluid pressure that provides for the normal functioning of thedevice. The fluid flow indicator is highly reliable in operation, can beproduced inexpensively, and, because it has very few parts, is easy tomanufacture.

[0028] As previously mentioned, the novel fill assembly for use infilling the reservoir of the reservoir assembly comprises a novel vialassembly which can be operably mated with the reservoir assembly for thecontrolled filling thereof at time of use.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029]FIG. 1 is an exploded, generally perspective bottom view of oneform of the apparatus of the present invention in which the reservoir ofthe fluid delivery device is filled by a vial assembly of novelconstruction.

[0030]FIG. 2 is a side-elevational, cross-sectional, exploded view ofthe vial assembly shown in FIG. 1.

[0031]FIG. 3 is a side-elevational, cross-sectional view of theapparatus of FIG. 1 showing the vial assembly coupled with the reservoirassembly of the fluid delivery device.

[0032]FIG. 3A is a generally perspective exploded view of the sterilecover subassembly of the invention for closing the vial assemblyreceiving chamber of the fluid delivery device.

[0033]FIG. 4 is an enlarged, generally perspective, exploded view of thevial assembly receiving chamber of the reservoir assembly showing thevial assembly in position to be mated with the reservoir assembly.

[0034]FIG. 5 is a cross-sectional view taken along lines 5-5 of FIG. 3.

[0035]FIG. 5A is a fragmentary, cross-sectional view of the areadesignated as 5A in FIG. 5.

[0036]FIG. 6 is a fragmentary, cross-sectional view similar to FIG. 5,but showing an alternate form of membrane capture means.

[0037]FIG. 7 is a side-elevational view of an alternate form ofreservoir fill assembly.

[0038]FIG. 8 is a generally perspective bottom view illustrating themanner of filling the reservoir using the reservoir fill assembly shownin FIG. 7.

[0039]FIG. 9 is a side-elevational, cross-sectional, exploded viewshowing an alternate form of the apparatus of the invention in which theblunt end cannula of the reservoir assembly has been replaced with aneedle like piercing cannula.

[0040]FIG. 10 is a side-elevational, cross-sectional view of anapparatus similar to that depicted in FIG. 3, but showing an alternateform of reservoir fill assembly that uniquely embodies an adaptersubassembly that permits a vial assembly having a needle-type pierceableseptum to be mated with a reservoir assembly such as shown in FIG. 3which has a blunt end cannula.

[0041]FIG. 11 is an enlarged fragmentary, cross-sectional view of aproportion of the adapter subassembly shown in FIG. 10 with a portion ofa vial assembly having a needle piercing cannula mated therewith.

[0042]FIG. 12 is a generally perspective, exploded view of one form ofthe flow control and flow indicator means of the invention.

[0043]FIG. 13 is a generally perspective, exploded view similar to FIG.12 also illustrating the construction of the alternate form of flowcontrol and indicator means of the invention.

[0044]FIG. 13A is a generally perspective view of one form of theelastomeric boot component of the indicator means of the inventionwhich, in response to fluid pressure, acts upon the indicia carryingmeans of the flow indicating means.

[0045]FIG. 13B is a fragmentary, generally perspective view illustratingan alternate form of flow control means of the invention.

[0046]FIG. 13C is a fragmentary, generally perspective view illustratingyet another form of flow control means of the invention.

[0047]FIG. 14 is a fragmentary, side-elevational, cross-sectional viewof still another form of reservoir assembly of an alternate embodimentof the invention.

[0048]FIG. 15 is a fragmentary, side-elevational, cross-sectional viewsimilar to FIG. 10, but showing the fill means of this alternate form ofthe invention being mated with the reservoir assembly.

[0049]FIG. 16 is an enlarged, cross-sectional view taken along lines16-16 of FIG. 15.

[0050]FIG. 17 is a generally perspective bottom view of an alternateform of the fluid delivery apparatus of the invention.

[0051]FIG. 18 is a generally perspective, top view of the apparatusshown in FIG. 17.

[0052]FIG. 19 is a fragmentary, cross-sectional view of the forwardportion of the form of the fluid dispensing apparatus shown in FIG. 18.

[0053]FIG. 20 is a front view of the apparatus showing the closure meansof the invention in an open configuration.

[0054]FIG. 21 is a cross-sectional view taken along lines 21-21 of FIG.20.

[0055]FIG. 22 is a cross-sectional view taken along lines 22-22 of FIG.20.

[0056]FIG. 23 is an enlarged, exploded, cross-sectional view of thefluid flow control means of this latest form of the invention.

[0057]FIG. 24 is a view of the flow control means of FIG. 23 shown inassembled configuration.

[0058]FIG. 25 is an exploded, generally perspective front view of thesupport structure of the fluid delivery apparatus of the form of theinvention shown in FIGS. 17 and 18

[0059]FIG. 26 is an exploded, generally perspective, rear view of theapparatus shown in FIG. 25.

[0060]FIG. 27 is a generally perspective, bottom view of another form ofthe apparatus of the invention.

[0061]FIG. 28 is a generally perspective top view of the apparatus shownin FIG. 27.

[0062]FIG. 29 is a front view of the fluid dispensing apparatus shown inFIG. 28.

[0063]FIG. 30 is a cross-sectional view taken along lines 30-30 of FIG.29.

[0064]FIG. 31 is a fragmentary, cross-sectional view taken along lines31-31 of FIG. 29 showing the forward portion of the fluid deliveryapparatus.

[0065]FIG. 32 is a fragmentary top view of the forward portion of thislatest form of the invention showing the circumferentially extendingchannel which is provided for storage of the delivery line of theapparatus.

DESCRIPTION OF THE INVENTION

[0066] Referring to the drawings and particularly to FIGS. 1 through 5,the apparatus of this form of the present invention is there illustratedand identified generally by the numeral 150. In order to avoid possibleconfusion with the numbering of U.S. Ser. No. 08/432,221, which isincorporated herein by reference, numbering of the drawings of theapplication will start with the numeral 150.

[0067] As best seen in FIGS. 1 and 3, the apparatus here comprises fourmajor cooperating subassemblies namely, a reservoir subassembly 150 a, aflow rate control subassembly 150 b, a flow indicator subassembly 150 cand a fill assembly 150 d. Each of these subassemblies will be discussedin greater detail in the paragraphs which follow.

[0068] Considering first the reservoir subassembly shown in FIG. 3, thissubassembly includes a base assembly 152, a stored energy source, shownhere as a distendable membrane component 154, and a cover 156 forenclosing the stored energy source. The base assembly includes an ullagesubstrate 158 and a membrane capture housing 160 having a bottom opening162 which receives the distendable membrane engaging element orprotuberance 164 (see also FIG. 5) of base assembly 152.

[0069] Referring particularly to FIGS. 3 and 5, the ullage substrate 158is provided with fill assembly receiving means shown here as alongitudinally extending, generally cylindrically shaped receivingchamber 165 for receiving the fill assembly 150 d. Provided withinchamber 165 are the valve and cannula means of the invention, the natureand purpose of which will presently be discussed. As best seen byreferring to FIGS. 1 and 2, one form of the fill assembly 150 d of theapparatus comprises a container subassembly 170 and an adaptersubassembly 172. Container subassembly 170 includes a body portion 176,having a fluid chamber 178 for containing an injectable fluid. Chamber178 is provided with first and second open ends 180 and 182 (FIG. 2).First open end 180 is sealably closed by closure means here provided inthe form of a pierceable septum assembly 184 which includes a septum 184a. Septum 184 a is pierceable by the cannula means of the inventionwhich is shown in FIGS. 3 and 4 as a blunt end, hollow cannula 185.Septum assembly 184 is held securely in position within open end 180 byclamping ring 186. As best seen in FIGS. 2 and 3, to expel fluid fromchamber 178, a plunger 188 is telescopically movable within the chamberfrom a first location where it is proximate second open end 182 to asecond position shown in FIG. 3 where it is proximate first open end180. The vial or body portion of the container subassembly 170 can beconstructed of various materials such as glass and plastic.

[0070] Referring particularly to FIG. 2, it can be seen that the adaptersubassembly 172 of this form of the invention comprises a hollow housing190 in the manner shown in having a first open end 192 and a secondclosed end 194. Container subassembly 170 is telescopically receivablewithin open end 192 of housing 190 in the manner shown in the drawingsso that the housing can be moved from the first extended position shownin FIG. 1 to the vial encapsulation position shown in FIG. 3. Forming animportant part of the adapter subassembly is pusher means shown here asan elongated pusher rod 196 which functions to move plunger 188 withinfluid chamber 178 from the first position shown in FIG. 1 to the secondposition shown in FIG. 3. In the form of the invention shown in thedrawings, pusher rod 196 has a first end 196 a interconnected withclosure wall 194 and an opposite end 196 b which engages plunger 188 andcauses telescopic movement of the plunger within chamber 178 ofcontainer subassembly 170 as housing 190 is moved from the extendedposition shown in FIG. 1 into the vial encapsulating position shown inFIG. 3.

[0071] As best seen by referring to FIGS. 1 and 3, receivable within themouth of chamber 165 of substrate 158 is a retaining ring 191 having analignment protuberance 197 which engages and centers adapter subassembly172 within chamber 165. Due to the small surface area presented byprotuberance 197, there is little frictional resistance to the slidingmovement of the adapter subassembly relative to base assembly 152 as theadapter subassembly is moved from the extended position shown in FIG. 1into the vial encapsulating position shown in FIG. 3.

[0072] Turning particularly to FIGS. 1, 3, and 3 a, it is to be notedthat prior to the fill assembly being inserted into chamber 165, thechamber is maintained in a sterile condition by a sterile tear-off coverassemble 200 which is bonded or otherwise removably affixed to retainingring 191. An integral pull tab 200 a is provided to permit the tear-offcover 200 b to be pulled from retaining ring 191 so as to permitinsertion of the fill assembly into chamber 165. Assembly 200 alsoincludes a resilient tab-like element 200 c (FIG. 3A) which lockablyengages saw tooth-like protuberances 190 a formed on adapter subassembly172 to prevent removal of the adapter subassembly from chamber 165 afterit has been fully inserted therewithin. As best seen in FIG. 1, amedicament label 204 circumscribes adapter portion 172 and serves toidentify the contents of container subassembly 170 prior to mating thefill assembly with the dispensing device. It is also to be noted thatcontainer subassembly 170 is provided with indicator means shown here asa plurality of spaced-apart index lines 206, which, by viewing thecontainer assembly through a window 207 provided in substrate 158 (FIG.1), permit the user to determine how much fluid remains within thecontainer at any given time.

[0073] As plunger 188 is moved forwardly of container 170 by theinsertion of the fill assembly into chamber 165, the fluid contained inthe container will flow under pressure into passageway 218 via the valvemeans which is here provided as an umbrella type check valve 209. Asbest seen in FIG. 4, valve 209, which is of a conventional construction,is received within a cavity 165 a formed in the end wall of receivingchamber 165 and is held in position therewithin by a cylindricallyshaped housing 185 a having an end wall 185 b which supports cannula 185in the manner shown in FIG. 4. Valve 209 is constructed from anappropriate elastomer and has a resiliently deformable skirt portion 209a which will deform inwardly within cavity 165 a to permit fluid to flowtoward the reservoir of the device, but will block reverse flow. Frompassageway 218, the fluid will flow under pressure into reservoir 220where it will cause the stored energy means or membrane 154 to distendoutwardly from protuberance 158 a of ullage substrate 158 in the mannershown in FIGS. 3 and 5.

[0074] As before, the stored energy means can be in the form of a singleprestressed or unstressed isotropic, elastomeric distendable membrane,or it can comprise a laminate assemblage made up of a plurality ofinitially generally planar distendable elements or films. In particular,as shown in FIG. 5A, the layer 154 a that will be in contact with thefluid may be a fluoroelastomer coating of the type made by LaurenInternational, Inc. that is known by the tradename Flurolast WB®. Theouter layer 154 can be any suitable elastomer having the characteristicsbest suited for the end application to be made of the device. Aspreviously discussed, as the distendable membrane 154 is distended bythe fluid pressure exerted by the fluid flowing into the reservoir,internal stresses are formed therein which continuously urge theassemblage toward engagement with protuberance 158 a as it tends toreturn toward its original configuration. As the membrane moves towardprotuberance 158 a, fluid within reservoir 220 will be uniformly andcontrollably forced outwardly through reservoir outlet 222, throughpassageway 224 and finally through longitudinally extending passageway226 which is formed in ullage substrate 158.

[0075] As indicated by FIGS. 3 and 5, upstanding tongue 164 of base 152extends completely about the perimeter of the base and is closelyreceivable within a groove 160 a of capture housing 160. When the ullagesubstrate and the membrane capture housing are assembled in the mannershown in FIGS. 3 and 5, the periphery of distendable membrane 154 willbe securely clamped within groove 160 a by tongue 164. After the partsare thus assembled, housing 160 is bonded to base 152 by any suitablemeans such as adhesive or sonic bonding. This done, cover 156 is matedwith capture housing 160 in the manner shown in FIGS. 3 and 5 and bondedin place.

[0076] Referring next to FIG. 6, an alternate form of the apparatus ofthe invention is there shown. This embodiment is virtually identical inconstruction and operation to that shown in FIGS. 3 and 5 save that thebase 153 is provided with a pair of circumferentially extending tongues153 a which tongues are closely receivable within a pair of grooves 161a provided in the capture housing 161. With this construction, when themodified ullage substrate and the modified membrane capture housing areassembled in the manner shown in FIG. 6, the periphery of distendablemembrane 154 will be securely clamped within grooves 161 a by tongues153 a. After the parts are thus assembled, housing 161 is bonded to base153 by any suitable means such as adhesive or sonic bonding.

[0077] Once again, reference should be made to U.S. Ser. No. 08/432,221for the various materials that can be used to construct the baseassemblies 152 and 153, the cover 156, and the membrane capture housings160 and 161 as identified in the preceding paragraphs.

[0078] Turning now to a consideration of the important flow rate controlsubassembly of this latest form of the invention, this subassembly issomewhat similar to that previously described and also includes flowcontrol means which are disposed externally of reservoir 220 forcontrolling the rate of fluid flow of fluid from the device. This flowcontrol means here comprises a rate control means, here shown asmembrane 230 (FIG. 12), which is closely received within a circularrecess 232 formed in support means shown here as comprising a supportstructure 234. Rate control membrane 230 comprises a very thin(approximately 0.018 inch thick), rigid polyester plate having amultiplicity of small laser drilled orifices 236. It is to be understoodthat rate control membrane 230 can be constructed from materials otherthan polyester, including those materials identified in U.S. Pat. No.5,205,820 which patent is incorporated herein by reference.

[0079] Referring to FIG. 13B, an alternate form of the flow controlmeans of the invention is there shown. This flow control means is usablewith the various components previously described and here comprises arate control membrane 230 a of slightly different construction, which isclosely received within a circular recess 232 formed in supportstructure 234 (see FIG. 12). Rate control membrane 230 a comprises avery thin (approximately 0.018 inch thick), rigid polyester plate havingonly a single small laser drilled orifice 236 a. This rate controlmembrane 230 a can also be constructed from various materials includingthose materials identified in U.S. Pat. No. 5,205,820.

[0080] Also comprising a part of the flow control means of this latestform of the invention is a vent patch or membrane 287, which is of thecharacter previously described, and filter means shown here as a thinmembrane 237. Filter membrane 277 is positioned proximate rate controlmembrane 230 a and functions to filter particulates from the fluidsflowing from passageway 262 toward rate control membrane 230 a (see alsoFIG. 13). Filter membrane 237 can be constructed from a number of porousmaterials such as metal and ceramics. A polyether sulfone material soldby Gelman Sciences under the name and style “SUPOR” has also provensatisfactory.

[0081] Turning next to FIG. 13C, still another form of flow controlmeans of the invention is there shown. This flow control means is alsousable with various components previously described and here comprisesfrit or rate control membrane 230 a which is also closely receivedwithin a circular recess form in support structure 234 (see FIG. 13).Rate control frit 230 b here comprises a rigid, porous glass frit of acharacter well known in the art which can be tailored to provide thedesired flow rate.

[0082] Also comprising a part of the flow control means of this latestform of the invention is a small version of the previously identifiedmembrane 287, here identified as 287 a. Also forming a part of this flowcontrol means is the previously identified filter membrane 237. Filtermembrane 277 is positioned proximate rate control frit 230 b and, asbefore, functions to filter particulates from the fluids flowing frompassageway 262 toward rate control frit 230 b (see FIG. 13).

[0083] Support structure 234 includes an outwardly extending generallycylindrically shaped, fluid inlet element 240 (FIG. 13) which isprovided is a fluid passageway 242. Passageway 242 is adapted tocommunicate with reservoir 220 via passageways 224 and 226 when supportstructure 234 is mated with base assembly 152. As best seen in FIG. 3,base assembly 152 has a centrally disposed socket-like recess 244 thatclosely receives inlet element 240 when structure 234 is mated with baseassembly 152.

[0084] Formed on either side of element 240 are wing-like protuberances248 (FIG. 13) which are received within spaced-apart, arcuate-shapedcavities formed in base assembly 152 (not shown). Located proximate theupper edge of support structure 234 are arcuately, spaced-apartconnector members 252 which mate with arcuately spaced openings 254provided on cover 156 to enable secure interconnection of supportstructure 234 with the reservoir assembly.

[0085] As shown in FIG. 3, when the support structure 234 is mated withthe reservoir assembly, fluid inlet passageway 242 is placed in fluidcommunication with reservoir 220 via passageways 224 and 226. With thisconstruction, when fluid is forced through fluid passageway 242 of inlet240 by the stored energy means, the fluid will flow into a verticallyextending passageway 256 formed in a thin manifold plate 260 (FIG. 13)which is closely receivable within a similarly shaped cavity 261 formedin the forward face of element 234 (FIG. 12). Next, the fluid will flowinto a horizontally extending passageway 262 formed in manifold plate260 and finally into a chamber 264 formed in a distendable, elastomericfirst boot 266 of the flow indicator means of the invention. As shown inFIG. 13A, boot 266 includes a yieldably distendable fluid flow blockingbody portion 266 a which is circumscribed by a marginal portion 266 b.Marginal portion 266 b is clamped between manifold plate 260 and auniquely configured indicator base 268 so that the boot extends througha generally arcuate-shaped opening 268 a formed in the indicator base268. It is to be understood that, when the fluid flowing from reservoir220 fills passageways 256 and 262 and impinges upon boot 266, flow willbe diverted back in the direction of arrows 269 of FIGS. 12 and 13toward support structure 234 and into a chamber 270 which is formed inthe rear surface of the support structure (FIG. 13). Chamber 270 isadapted to closely receive an angularly shaped insert 271 of thecharacter shown in FIG. 12. As shown in FIG. 12, insert 271 includes ahorizontally extending fluid passageway 272 having an inlet end 272 aand an outlet end 272 b. Insert 271 also has a vertically extendingfluid passageway 274 having an upper inlet end 274 a and a lower outletend 274 b which terminates in a socket-like cavity 276. Cavity 276 is incommunication with a tubular quick-connect coupling 280 formed onsupport structure 234 (FIG. 12). In a manner presently to be described,tubular extension 280 is adapted to mate with a quick disconnect outletadapter 280 a which is, in turn, connected to the fluid delivery line281 of the apparatus (FIG. 1).

[0086] It is to be observed that fluid which is diverted back from boot266 toward support structure 234, will flow in the direction of thearrow 269 of FIG. 13, through rate control element 230, and then intoinlet end 272 a of passageway 272 formed in insert 271. After flowingthrough rate control element 230, the fluid will next flow alongpassageway 272 toward the outlet end 272 b in the direction of arrow 283(FIG. 13) and then outwardly of the passageway through an outlet port284 formed in support structure 234. Next, the fluid will flow forwardlyin the direction of arrow 286 through an orifice 288 formed in plate 260where it will impinge on a second elastomeric, distendable boot 286which also forms a part of the indicator means of the invention.Indicator boot 286, which is of identical construction to boot 266, isclamped within an oval shaped opening 268 b formed in indicator base268. After impinging on boot 286, the fluid will next flow back towardsupport structure 234 in the direction of arrow 287, through a lowerorifice 290 formed in plate 260 and then, via orifice 291 formed instructure 234, into the upper inlet end 274 a of passageway 274 which isformed in insert 271. Upon entering passageway 274, the fluid will flowdownwardly of the passageway into cavity 276 and then into tubularextension 280 where it can enter the quick disconnect outlet adapter 280a and finally delivery line 281.

[0087] It is to be noted that fluid flowing from reservoir 220 intopassageway 240 and then on toward boot 266 is under a higher pressurethan fluid flowing toward boot 286. This is because the pressure of thefluid flowing toward boot 286 has been reduced as a result of the fluidflowing through rate control element 230. It should also be noted thatvent means, shown here as a vent patch 287, is provided in the system topermit air trapped within the flow control assembly to be vented via aport 289 formed in plate 260.

[0088] Next to be considered is the important flow indicator means ofthe invention, which functions to distinguish among three conditions ofoperation, namely normal fluid flow, fluid flow blockage or occlusion,and reservoir empty. Turning particularly to FIGS. 3, 12, and 13, theflow indicator means here comprises the previously identified indicatorbase or platform 268, as well as the boot clamping plate 260.Additionally, the indicator means comprises a support or lens plate 300,and a hollow housing 302 within which the platform and the support plateare enclosed (FIG. 3). As seen in FIG. 3, a viewing lens 301 is viewablethrough an aperture 302 a provided in housing 302.

[0089] Disposed between platform 268 and plate 300 are first and secondindicia-carrying means shown here as a pair of closely adjacent, thinfilms. These films, identified here as 306 and 308, are in intimatecontact and are preferably constructed from a substantially transparent,flexible polymer material such as mylar. It is to be understood that theindicia-carrying means need not be thin films, but rather can be anytype of surface presenting member upon which indicia can be provided.The downstream surface of the inferior or first film 306 is printed withthree integrated symbols 307 (FIG. 12), which may comprise, by way ofexample, a blue circle, a green arrow, and a red X, each consisting ofdiagonal strips of color printed in an alternating pattern (blue, green,red, blue, green, red, and so on (see also FIGS. 25 through 29 of U.S.Ser. No. 08/432,221 which is incorporated herein by reference). Thesecond film 308 serves as a “mask” over film 306 and is printed with apattern of diagonal alternating clear and opaque strips 308 a that occurin approximately a 1:2 ratio. The printed ratio of the “mask” allowsonly one colored symbol to appear at a time when viewed through viewinglens 301. The inferior and superior films are provided at their oppositeends with apertures 310 which receive retention pins 312 provided onplatform 268 (FIG. 12) which permit attachment of the film to platform268 in a manner such that the non-patterned portions of each film coversboot openings 268 a and 268 b provided proximate each end of platform268 with the patterned portions of both the superior and inferior filmsbeing maintained in index. With this construction, each thin film isable to move in response to pressure exerted thereon by the elastomericboots in opposing directions parallel to the film plane with its rangeof motion limited to one axis in the film plane by edge guides 318provided on platform 268 (FIG. 12). As the films move, the visiblesymbol pattern will, of course, change due to the transversedisplacement of the patterns imprinted thereon.

[0090] As is apparent from a study of FIG. 13, the central portions ofboth the first and second elastomeric actuator elements or boots 266 and286 will be deflected outwardly toward plate 300 when the device isfilled and primed, but not in a state of delivery or when there is abuild up of fluid pressure during delivery that is caused by blockage ofthe delivery line downstream from boot 286. While boot 266 can bedeflected by normal line pressure, boot 286 is deflected only bypressure buildup resulting from the downstream blockage. When bothelastomeric boots 266 and 268 are deflected outwardly, both the superiorand inferior films are displaced transversely to a second positionrevealing a second symbol, as for example, an X as viewed through theviewing aperture of the support plate (see also FIGS. 28 and 29 of U.S.Ser. No. 08/432,221 which is incorporated herein by reference).

[0091] A third alignment of symbol patterns as shown in FIGS. 24 and 25of U.S. Ser. No. 08/432,221 (which is incorporated herein by reference)is visible when the device is in an unfilled state or when the deliveryline is open, the reservoir is empty and fluid delivery to the patienthas been completed. In this case, there is no fluid pressure in the lineon either the upstream or the downstream side of the flow control meansand thus both the first and second boots are in a non-deflectedposition. In this condition, the inferior and superior films are nottransversely displaced and thus exhibit a third combination of patternsresulting in a third symbol as, for example, a circle being visiblethrough the viewing aperture of the support plate. Boots 266 and 286 canbe precisely tailored to deflect under various pressures therebypermitting great apparatus versatility.

[0092] Turning next to FIGS. 7 through 9, still another form of theapparatus of the invention is there shown and generally designated bythe numeral 330. This embodiment is similar in many respects to theembodiment shown in FIGS. 1 through 8 and like numerals have been usedto identify like components. More particularly, only the reservoir andfill subassemblies of the device have been modified, with the flow ratecontrol subassembly and the indicator subassembly of the deviceremaining unchanged.

[0093] With regard to the modified reservoir subassembly which is shownin FIG. 9, this subassembly includes a base assembly 332, a distendablemembrane component 154, and a cover 156 for enclosing the membrane.While the base assembly 332 includes a slightly modified ullagesubstrate 334, the membrane capture housing 160 is virtually identicalto that previously described and includes a bottom opening 162 whichreceives the basically unchanged distendable membrane engaging elementor protuberance 164 of base assembly 332. As before, the modified ullagesubstrate 334 is provided with fill assembly receiving means shown hereas a longitudinally extending, generally cylindrically shaped receivingchamber 336 for receiving the fill assembly 340 which is also of aslightly different construction from that shown in FIGS. 1 through 8. Asbest seen in FIG. 9, the cannula means of the latest form of theinvention comprises a sharp, needle-like, hollow cannula 342, ratherthan a blunt end cannula.

[0094] The fill assembly 340 of this latest embodiment of the inventioncomprises a container subassembly 344 and an adapter subassembly 346.Container subassembly 344 includes a body portion 348, having a fluidchamber 350 for containing an injectable fluid “F”. Chamber 350 isprovided with first and second open ends 352 and 354. First open end 352is sealably closed by closure means here provided in the form of apierceable septum assembly 356 which includes a septum 358. Septum 358is pierceable by the needle-like sharp cannula mounted within receivingchamber 336. Septum 358 is held securely in position within open end 352by clamping ring 360. As before, in order to expel fluid from chamber350, a plunger 188 is telescopically movable within the chamber from afirst location where it is proximate second open end 354 to a secondposition where it is proximate first open end 352.

[0095] The adapter subassembly 340 of this form of the inventioncomprises a hollow housing 364 having a first open end 366 and a secondclosed end 368. Container subassembly 344 is telescopically receivablewithin open end of chamber 336, then the adapter subassembly 340 isintroduced to open end of chamber 336 when pusher rod engages plunger ofvial. Adapter subassembly 340 also includes an elongated pusher rod 370which functions to move plunger 188 within fluid chamber 350 from afirst extended position to the second position proximate septum assembly356 as the fill assembly is mated with the reservoir assembly.

[0096] As best seen in FIG. 9, provided within chamber 336 is an innercylindrically shaped wall 336 a which is concentric with the inner wall336 b of receiving chamber 336, forms an integral part of ullagesubstrate 334 and is radially spaced from the inner wall 336 b ofchamber 336 so as to define a longitudinally extending annular space 336c. With this construction, during the mating of the reservoir fillassembly with the reservoir assembly, the outer wall 364 a of hollowhousing 364 is closely receivable within space 336 c as the adaptersubassembly is urged inwardly of chamber 336. At the same time that wall364 a moves forwardly of annular space 336 c, the container assemblytelescopes inwardly of hollow housing 364 and is guided thereby so as tomove septum 358 into piercing engagement with sharp end cannula 342.

[0097] Prior to the reservoir fill assembly being mated with thereservoir assembly, chamber 336 is maintained in a sterile condition bya sterile tear-off cover assembly 374 which is bonded or otherwiseremovably affixed to the wall of a counter bore 376 formed in ullagesubstrate 334. An integral pull tab 374 a is provided to permit thecover 374 b to be pulled free so as to permit insertion of the reservoirfill assembly into chamber 336. Cover assembly also includes an inwardlyextending tab 374 c which engages teeth-like protuberances 357 formed onwall 364 a of the fill adapter so as to prevent removal thereof afterthe fill assembly has been mated with the reservoir assembly.

[0098] As plunger 188 of the container assembly is moved forwardly ofcontainer 344 by pusher rod 370, the fluid contained in the containerwill flow under pressure into a passageway 380 via hollow cannula 342and via an umbrella type check valve 382 which is of similarconstruction and operation to valve 209. Valve 382 is received within acavity 332 a formed in the end wall of receiving chamber 336 and is heldin position therewithin by a disc-shaped member 384 which supportscannula 342 in the manner shown in FIG. 9. Valve 382 is constructed froman appropriate elastomer and has a resiliently deformable skirt portion382 a which will deform inwardly within cavity 332 a to permit fluid toflow toward the reservoir of the device but will block reverse flow.From passageway 380, the fluid will flow under pressure into reservoir390 where it will cause the stored energy means or membrane 154 todistend outwardly from ullage substrate 334 n the manner shown in FIG.9.

[0099] After the reservoir has been filled and as membrane 154 movestoward substrate 334 during the fluid dispensing step, fluid withinreservoir 390 will be uniformly and controllably forced outwardlythrough reservoir outlet 392, through a passageway 394 and then intopassageway 242 of the fluid inlet to substrate 234 of the flow controlmeans (see for example FIG. 3).

[0100] As shown in FIG. 9, the embodiment of this latest form of theinvention also includes a uniquely designed auxiliary filling meansmounted on ullage substrate 334 which enables filling of reservoir 390other than by mating the fill assembly 340 with the reservoir assembly.This auxiliary filling means here comprises a generally cylindricallyshaped housing 402 having a fluid inlet 402 a and a fluid outlet 402 bin communication with reservoir 390. Housing 402 terminates at its inletend in a conventional luer type connector end 404 and includes valvemeans for controlling fluid flow between inlet 402 a and outlet 402 b.Valve means 400 here comprises a valve seat 406 which is adapted tosealably engage a tapered shoulder 408 formed on a generallycylindrically shaped valve member 410. Valve member 410 is mountedwithin housing 402 for reciprocal movement therewithin between a valveclosed position shown in FIG. 9 and a valve open position whereintapered surface 408 is moved away from valve seat 406 a distancesufficient to permit fluid flow toward reservoir 390. An apertured cover412 closes the upper open end of housing 402 with the aperture 414 whichis provided therein in alignment with a reservoir inlet passageway 416.

[0101] In using the auxiliary fill means of the invention, a sanitaryclosure cap 417, which is temporarily received over luer connector end404 is first removed. This done, a conventional luer-type connector canbe interconnected with end 404 of housing 402 so as to opencommunication between the interior of housing 402 and a conventionalfill line interconnected with the luer connector (not shown). The luerconnector and fill line is of standard construction and, in thisinstance, includes an outwardly extending pintle which engages valvemember 410 as the luer connector is mated with housing 402 so as to movevalve member 410 into its second open position permitting fluid to flowfrom the fluid delivery line past valve member 410 and into reservoir390 via inlet 416. Such a luer connector construction is well understoodby those skilled in the art. It is to be observed that the auxiliaryfill means can be used as the primary fill means for filling thereservoir or, alternatively, can be used to add an appropriate additivefluid to fluid earlier dispensed into the reservoir 390 by the vial-typefill assembly 340.

[0102] Referring next to FIGS. 7 and 8, still another form of fill meansof the invention is there shown. This alternate fill means comprises apistol grip-type fill device 420 which is usable with a reservoirassembly of the character shown in FIG. 8 which is similar inconstruction to the reservoir assembly shown in FIG. 9. As best seen inFIG. 7, fill device 420 includes a hollow barrel portion 422 and aninterconnected hand grip portion 424. Provided at the forward end ofbarrel portion 422 is a septum assembly 426 which includes a pierceableseptum of the same general character as pierceable septum 358 shown inFIG. 9. Provided at the opposite end of barrel 420 from septum assembly426 is a connector means 428 for interconnecting the interior of barrelportion 422 with a fill line 430 which is, in turn, connected to apressurized source of medicinal fluid of the character to be used in thefilling of reservoir 390.

[0103] The fill means of this latest form of the invention is used inconnection with the modified reservoir assembly shown in FIG. 9 byholding the reservoir in one hand in the manner shown in FIG. 8. Withthe pistol grip fill means held in the other hand as shown in FIG. 8,barrel 422 is inserted into chamber 336 and pushed forwardly of the baseassembly to cause cannula 342 to pierce septum assembly 426 therebyopening communication between supply line 430 and reservoir 390 of thereservoir subassembly. It is to be understood that the reservoirassembly usable with the pistol grip filling means shown in FIG. 7 canalso be of the character shown in FIG. 4 which is provided with a bluntend cannula 185 rather a needle-like cannula 342 as shown in FIG. 8. Inthis instance, the septum assembly 426 will, of course, embody a splitseptum rather than a needle-piercing septum so as to accommodate theblunt-end cannula.

[0104] Turning next to FIGS. 10 and 11, still another embodiment of theinvention is there shown and generally designated by the numeral 440.This embodiment is also similar in many respects to the embodiment shownin FIGS. 1 through 8 and like numbers have been used to identify likecomponents. More particularly, only the fill assembly 444 and thehousing 442, which supports the blunt end cannula 185, have beenmodified with the remainder of the device remaining unchanged. The mainpurpose of this latest embodiment of the invention is to provide meansfor coupling a container assembly having a standard needle piercingseptum with a reservoir assembly having a blunt end cannula.

[0105] As shown in FIG. 10, modified housing 442 of the reservoirassembly of this latest form of the invention supports the blunt endcannula 185 in the manner previously described. However, the inner wall442 b of the skirt portion 442 a thereof is provided with acircumferentially extending bead or protuberance 442 c which, in amanner presently to be described, lockably engages a portion of themodified fill assembly 444.

[0106] The modified fill assembly 444 of the form of the invention shownin FIGS. 10 and 11 comprises a hollow housing 448 having a first openend 450 and a closed second end 452. The container subassembly, which isof identical construction to the container subassembly 340 shown in FIG.9, is telescopically receivable within the open end 453 a of a secondhousing 453 which is, in turn, receivable within housing 448 in themanner shown in FIG. 39. Second housing 453 is of a novel generallycylindrically shaped construction of a character presently to bedescribed. As shown in FIG. 10, assembly 444 includes an elongatedpusher rod 454 which, as the fill assembly is mated with the reservoirassembly, functions to move plunger 188 of the container subassemblytelescopically of fluid chamber 350 from a first extended position tothe second position proximate septum assembly 356.

[0107] As best seen by referring to FIG. 11, second housing 453 includesa hollow, central body portion 460 and a forward end portion 462 havingan open end 462 a and a circumferentially extending bead or protuberance462 b surrounding open end 462 a. Sealably closing open end 462 is asplit septum 464 which is of a conventional construction adapted tosealably receive a blunt end cannula such as cannula 185 which iscarried by modified housing 442.

[0108] Extending through and supported by a wall 466 which divides bodyportion 460 and forward portion 462 of second housing 453 is a sharpneedle-like hollow cannula 470 which is adapted to sealably pierceseptum 358 of container assembly 340.

[0109] In using the apparatus of this latest embodiment of theinvention, container assembly 340 is first inserted into open end 453 aof second housing 453 and is urged forwardly to the position shown inFIG. 11 wherein needle-like cannula 470 pierces septum 358. This stepopens communication between fluid chamber 350 of the container assemblyand a subchamber 471 formed in the forward portion 462 of second housing453 and in communication with chamber 473 which sealably receives splitseptum 464. After removing a protective cap 472 which closes open end462 a of forward portion 462, the assembly made up of second housing 453and fluid container assembly 340 is mated with hollow housing 448. Theassemblage is then urged forwardly of chamber 165 which causes pusherrod 454 to move plunger 188 of the container assembly forwardly ofchamber 350. As the assemblage seats the split septum 464 will besealably pierced by blunt end cannula 185. This step opens fluidcommunication between chamber 350 of the container subassembly andchamber 332 a which houses check valve 382. As before, as the fluidcontained within chamber 350 of the container subassembly is urgedoutwardly of the container by forward movement of plunger 188, the fluidcontained within the container assembly will flow through hollow needle470, through hollow blunt end cannula 185, past umbrella check valve 382and into reservoir 220 via inlet portion 218. As shown in FIG. 10, whenthe fill assembly seats within receiving chamber 165, protuberance 462 bformed on second housing 453 will move past protuberance 442 c formed inskirt 442 a of the cannula support housing thereby locking secondhousing 453 against removal from the reservoir assembly. Similarly, tab374 c formed on closure cap assembly 374 will lockably engage the sawtooth shaped protuberance 475 formed on housing 448 so as to preventremoval of housing 448 from the reservoir assembly.

[0110] It is apparent that with this latest embodiment of the invention,a container subassembly of the character shown in FIG. 9 which has astandard septum 358 can be readily mated with an apparatus of thecharacter shown in FIG. 10 which embodies a blunt end cannula 185,without having to modify either the container subassembly or thereservoir assembly.

[0111] Turning to FIGS. 14, 15, and 16, yet another embodiment of theinvention is there illustrated. This embodiment is generally similar tothe embodiment shown in FIG. 9 save that the reservoir assembly does notinclude the secondary fill means and save for the fact that the cannulameans is of a slightly different construction. Also different from theembodiment of the invention shown in FIG. 9 is the fill means of theinvention which is here designed to accommodate a fluid containersubassembly which has a diameter substantially less than the internaldiameter of wall 336 a of the base assembly. Because of the similarityof construction, like numerals are used to identify like components.

[0112] As best seen in FIG. 15, to accommodate a smaller diametercontainer assembly of the character there shown, a plurality ofring-like guide members 480 are positioned at longitudinally spacedapart locations along inner wall 336 a. Each of these ring-shaped guidemembers 480 includes a plurality of circumferentially spaced,resiliently deformable tabs 480 a which extend inwardly relative fromwall 336 a and function to guidably engage the outer wall of bodyportion 482 of the fluid container assembly 484 of this latest form ofthe invention (FIG. 15). Container assembly 484 includes a septumassembly 356 of the same general construction as shown in FIG. 9, thepierceable septum 358 of which is adapted to be pierced by the sharpend, needle-like cannula 342 which is supported by a slightlydifferently configured cannula support 493. As before, a plunger 486 ofthe container assembly is moved longitudinally of fluid chamber 488 by apusher rod 490 which forms a part of the hollow housing 492 of theadapter portion of the fill means. As before, as housing 492 of the fillmeans is inserted into annular space 336 c in the manner shown in FIG.15, pusher rod 490 will move plunger 486 forwardly of the fluidcontainer assembly causing fluid flow through cannula 342, past checkvalve 382, and into fluid reservoir 390 via an inlet 494. As adaptersleeve 492 is mated with the reservoir assembly, the fluid containerassembly will remain perfectly centered with respect to pusher rod 490due to the guiding action of tabs 480 a of guide rings 480.

[0113] Turning next to FIGS. 17 through 26, yet another form of theapparatus of the invention is there shown and generally identified by anumeral 500. This form of the apparatus is similar to that illustratedin FIGS. 1 through 5 and like numbers are used to identify likecomponents. However, in this latest embodiment only three majorcooperating subassemblies are provided, namely, a reservoir subassembly500 a, a flow rate control subassembly 500 b (FIG. 24), and a fillassembly 500 c (FIG. 18). An important feature of this latest embodimentis the provision of a highly novel closure means for closing the forwardend of the device. This closure means, which is best seen in FIGS. 18and 19 and is generally designated therein by the numeral 517. Thisimportant closure means will be further described in the paragraphswhich follow.

[0114] As indicated in FIG. 19, the reservoir subassembly 500 a of thislatest embodiment is quite similar to that shown in FIG. 3 and includesa base assembly 502, a stored energy source, shown here as a distendablemembrane component 504, and a cover 506 for enclosing the stored energysource in the manner previously discussed. The base assembly, only aportion of which is shown in FIG. 19, is of the same basic design asbase assembly 152 and includes an ullage substrate 508 as well as amembrane capture housing 510 which is of identical construction topreviously described capture housing 160. Housing 510 includes a bottomopening 512 which receives the distendable membrane engaging element orprotuberance 514 (see also FIG. 5) of base assembly 502.

[0115] As before, ullage substrate 508 is provided with fill assemblyreceiving means which takes the form of a longitudinally extending,generally cylindrically shaped receiving chamber which is similar inconstruction to previously described chamber 165 (FIG. 3), and whichfunction to receive a fill assembly 500 c which assembly is identical tofill assembly 150 d. Valve and cannula means of identical constructionand operation to that previously described are disposed within the fillassembly receiving chamber and cooperate with the fill assembly to fillreservoir 515.

[0116] As in the earlier discussed embodiments, the stored energy meanscan take the form of a single prestressed or unstressed isotropic,elastomeric distendable membrane, or it can comprise a laminateassemblage made up of a plurality of initially generally planardistendable elements or films. As the distendable membrane 154 isdistended by the fluid pressure exerted by the fluid flowing intoreservoir 515, internal stresses are formed therein which continuouslyurge the assemblage toward engagement with protuberance 508 a (FIG. 19)as it tends to return toward its original configuration. As the membranemoves toward protuberance 508 a, fluid within reservoir 515 will beuniformly and controllably forced outwardly through reservoir outlet518, through passageway 520 and finally through a longitudinallyextending passageway 522 which is formed in ullage substrate 508 (FIG.19).

[0117] As previously discussed, the upstanding tongue of base 502extends completely about the perimeter of the base and is closelyreceivable within a groove 510 a provided in capture housing 510. Whenthe ullage substrate and the membrane capture housing are assembled inthe manner shown in FIGS. 19, 3 and 28, the periphery of distendablemembrane 504 will be securely clamped within groove 510 a by tongue 514.After the parts are thus assembled, cover 506 is mated with the capturehousing 510 in the same manner as is shown in FIGS. 3 and 5 and then issuitably bonded in place.

[0118] Turning now to a consideration of the important cover means ofthis latest form of the invention, this means here comprises a housingassembly 528 which is interconnected with the reservoir subassembly 500a and functions to close the forward or delivery end of the device (seeFIGS. 18 and 19). As best seen in FIG. 19, housing assembly 528 includesa first or forward compartment 528 a and a second, or rearwardcompartment 528 b. Rearward compartment 528 b houses a support structure530, which is generally similar in construction to support structure 234(FIG. 3). Like support structure 234, support structure 530 includes anoutwardly extending, generally cylindrically shaped, fluid inlet element532 within which is provided a fluid passageway 534. When supportstructure 530 is mated with base assembly 502, passageway 534 willcommunicate with reservoir 515 via passageways 520 and 522. As before,base assembly 502 has a centrally disposed, socket-like recess 535 thatclosely receives inlet element 532 when structure 530 is mated with baseassembly 502 in the maimer shown in the drawings.

[0119] The flow control means of this latest form of the invention forcontrolling the rate of fluid flow of fluid from the device herecomprises a novel flow control assembly 540 of the character shown inFIGS. 23 and 24. As best seen in FIGS. 21 and 22, a rate controlassembly 540 is mounted within a socket like portion 542 formed in aninsert 544 which is received within a cavity 546 formed in the forwardwall 530 a of support structure 530 (see FIG. 26). Insert 544, incooperation with a fluid passageway 548 formed in support structure 530,functions to provide a fluid flow path between reservoir 515 and theflow control assembly 540. More particularly, assembly 540 herecomprises a quick disconnect housing 550 which has a central fluidpassageway 552 having an inlet 554 which communicates with passageway548 in the manner shown in FIGS. 21 and 22.

[0120] Interconnected with quick disconnect housing 550 is a deliveryline housing 556 to which a delivery line 558 is sealably connected.Disposed within housing 556 is an elastomeric compression ring 560 whichsealably receives the flow rate control means of this form of theinvention, which means is here provided as a generally cylindricallyshaped rate control frit 562. Also forming a part of the flow controlmeans of this latest embodiment is filter means, here shown as a filterelement 564 which is disposed between frit 562 and quick disconnecthousing 550 (FIG. 24). Frit 562 and filter element 564 are preferablyconstructed from the same type of materials as previously identifiedherein in connection with the discussion of elements 237 and 239.

[0121] When insert 544 is in position within cavity 546 in the mannershown in FIG. 22, quick connect socket portion 542 extends into forwardchamber 528 a of the closure means. With this construction, the flowcontrol means can be placed in fluid communication with the fluidreservoir of the device by inserting quick disconnect housing 550 intosocket portion 542 and then turning it in conventional fashion tosecurely lock it in position. To prevent leakage of fluid betweenhousing 550 and socket portion 542 an elastomeric O-ring 565 is providedin housing 550 (FIGS. 23 and 24).

[0122] Connected to the flow control means is the fluid delivery meansof the invention. This latter means, which is uniquely removably stowedwithin first or forward compartment 528 a of the closure means, herecomprises a delivery line luer assembly 570 and a line clamp 572 both ofwhich are of conventional construction. Previously identified deliveryline 558 is interconnected with luer assembly 570 in the manner shown inFIG. 18. Disposed between the flow control means and luer assembly 570is a vent means shown here as a conventional gas vent assembly 574 forventing gases trapped within the system to atmosphere.

[0123] Forward compartment 528 a is formed within an access door 576which is connected to that portion of the rearward portion of housing528 which defines rearward compartment 528 b, by hinge means here shownas a pair of living hinge elements 577. With this arrangement, door 576can be pivoted relative to the reservoir assembly from the closedposition shown in FIG. 19 to the open position shown in FIG. 18. Door576, which forms a part of closure means 517, includes a front face 576a which, in cooperation with an interconnected circumscribing wall 576b, forms forward compartment 528 a (FIGS. 18 and 20). Latching means,shown here as comprising an arcuate protuberance 579 formed on housing528, and an arcuate locking tab 581 formed on door 576, cooperate tolatchably maintain the door in a normally closed condition (FIG. 19).With this novel arrangement, the delivery means of the invention canremain securely stowed within compartment 528 a until time of use.

[0124] Turning next to FIGS. 27 through 31, still another form of theapparatus of the invention is there shown and generally identified by anumeral 600. This form of the apparatus is somewhat similar to thatillustrated in FIGS. 17 through 25 and like numbers are used to identifylike components. In this latest embodiment three major cooperatingsubassemblies are provided, namely, a reservoir subassembly 600 a, aflow rate control means 600 b (FIG. 24) and a fluid delivery means 600 cwhich is of the same basic character as is shown in FIGS. 17 and 18. Animportant feature of this latest embodiment is the provision of aclosure means of a slightly different construction for closing theforward end of the device and for stowing the delivery means in cavitiesprovided in the face of the closure means. This closure means, which isbest seen in FIG. 27 will be further described in the paragraphs whichfollow.

[0125] As indicated in FIG. 29, the reservoir subassembly 600 a of thislatest embodiment is virtually identical to reservoir subassembly 500 aand, therefore, will not here be described in further detail. Suffice tosay that the reservoir subassembly includes a stored energy source,shown as a distendable membrane component 504, and a cover 506 forenclosing the stored energy source in the manner previously discussed.The base assembly, only a portion of which is shown in FIG. 29, is ofthe same basic design as base assembly 522 and includes an ullagesubstrate 608 as well as a membrane capture housing 510 which is ofidentical construction to previously described capture housing 160.Since in this embodiment the reservoir is filled by an external fillline, or the like, no container type fill means is provided and,accordingly, the ullage substrate has no fill assembly receivingchamber. Reference should be made to FIG. 3B of Ser. No. 08/432,221which is incorporated by reference, wherein the details of constructionof the fill means of this latest form of the invention is shown.

[0126] With regard to the cover means of the form of the invention shownin FIGS. 27 and 28, this means here comprises a housing assembly 628which is interconnected with the reservoir subassembly 600 a andfunctions to close the forward or delivery end of the device (see FIGS.29 and 30). As best seen in FIG. 29, housing assembly 628 includes afirst or forward compartment 628 a and a second, or rearward compartment628 b. Rearward compartment 628 b houses a support structure 530, whichis generally similar in construction to support structure 234 (FIG. 3).Like support structure 234, support structure 530 includes an outwardlyextending, generally cylindrically shaped, fluid inlet element 532within which is provided a fluid passageway 534. When support structure530 is mated with base assembly 502, passageway 534 will communicatewith reservoir 515 via passageways 520 and 522. As before, base assembly502 has a centrally disposed, socket-like recess 535 that closelyreceives inlet element 532 when structure 530 is mated with baseassembly 502 in the manner shown in the drawings.

[0127] The flow control means of this latest form of the invention forcontrolling the rate of flow of fluid from the device is substantiallyidentical to that previously described and comprises a rate control frit562 and a filter element 564 (FIG. 59). These elements function in themanner described in connection with FIGS. 46 through 54 and areassembled together in the manner shown in FIGS. 23 and 24.

[0128] Interconnected to a quick disconnect housing 550 of the characterpreviously described is a delivery line housing 556 to which a deliveryline 558 is sealably connected (FIG. 30). As before, when the variouscomponents of the flow control assembly 540 are interconnected in themanner shown in FIG. 23 and when the assembly is in position withinsocket portion 542, the flow control means is in fluid communicationwith the fluid reservoir 515 of the device.

[0129] In addition to delivery line 558, the fluid delivery means ofthis latest form of the invention also comprises a delivery line luerassembly 570 and a line clamp 572 both of which are of the characterpreviously described. Disposed between the flow control means and luerassembly 570 is a vent means shown here as a conventional gas vent andfilter assembly 574, which is also of the character previouslydescribed.

[0130] As best seen in FIGS. 28, 30, and 31, the front face 628 c offorward compartment 628 a is formed with a plurality of cavity-likerecesses which receive portions of the delivery means. Moreparticularly, face 628 c has formed therein a cavity 570 a which closelyreceives luer assembly 570, a cavity 572 a which closely receives clamp572 and a cavity 574 a which closely receives gas vent assembly 574.Turning to FIG. 31, it is to be noted that delivery line 558 extendsdownwardly of forward compartment 628 a and passes through an opening575. The line can then be uniquely wound around housing 628 so that itsafely resides within a circumferentially extending channel 577 providedin the housing (FIGS. 28, 31, and 32). With this novel arrangement,until the device is to be used, the luer assembly 570, the roller clamp572, and the vent assembly 574 can be conveniently stowed with thecavities formed in face 628 c with the delivery line neatly wrappedaround the unit and securely stowed within channel 577. At time of use,the components can be quickly and easily removed from their respectivestorage cavities and the delivery line expeditiously unwound from theunit. Upon releasing the line clamp 572, and removal of luer aseptic cap570 b (FIG. 26) the stored energy means will then cause fluid to flowthrough the delivery line at a precisely controlled rate.

[0131] Having now described the invention in detail in accordance withthe requirements of the patent statutes, those skilled in this art willhave no difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

We claim:
 1. A device for use in infusing medical fluids comprising: (a)a base assembly including: (i) an ullage substrate having a receivingchamber formed therein; and (ii) a hollow cannula mounted within saidreceiving chamber; (b) stored energy means for forming in conjunctionwith said base assembly a fluid reservoir having an inlet incommunication with said hollow cannula and an outlet, said energystorage means comprising at least one distendable member superimposedover said base, said member being distendable as a result of pressureimparted by the fluids to be infused, to establish internal stresses,said stresses tending to move said member toward a less distendedconfiguration; (c) fill means for filling said fluid reservoir, saidfill means comprising a fill assembly including a container subassemblyand an adapter subassembly, said container subassembly comprising: (i) afill assembly including a fluid container and an adapter subassembly,for interconnecting said fluid container with said base assembly; and(ii) an auxiliary filling means including a housing connected to saidullage substrate, said housing having a fluid inlet in communicationwith said fluid reservoir, a fluid outlet spaced apart from said fluidinlet and valve means for controlling fluid flow between said fluidinlet and said fluid outlet; (d) an outlet port in communication withsaid outlet of said reservoir for dispensing fluids from the device; and(e) fluid actuated indicator means disposed intermediate said fluidoutlet of said reservoir and said outlet port for visually indicatingfluid flow from said fluid reservoir.
 2. A device as defined in claim 1in which said fluid container of said fill assembly has first and secondopen ends and in which said fill assembly further includes: (a)pierceable means for sealably closing one of said first and second openends of said container, said pierceable means being pierceable by saidhollow cannula; and (b) a plunger telescopically movable within saidcontainer from a first location proximate said pierceable means to asecond, spaced-apart location.
 3. A device as defined in claim 1 inwhich said indicator means comprises first and second at least partiallyoverlaying thin films, said film being movable relative to each other inresponse to fluid flowing from said fluid reservoir.
 4. A device asdefined in claim 1 further including flow control means disposedintermediate said indicator means and said outlet of said fluidreservoir for controlling the rate of flow of fluid from the device. 5.A device for use in infusing medicinal fluid into a patient at acontrolled rate comprising: (a) a base having a receiving chamber formedtherein; (b) a hollow blunt end cannula mounted within said receivingchamber of said base; (c) stored energy means for forming, inconjunction with said base a fluid reservoir having an inlet incommunication with said hollow cannula and an outlet, said energystorage means comprising at least one distendable member superimposedover said base, said member being distendable as a result of pressureimparted by the fluids to be infused, to establish internal stresses,said stresses tending to move said member toward a less distendedconfiguration; (d) container means interconnectable with said base forfilling said fluid reservoir said container means comprising: (i) acontainer having a fluid chamber with first and second open ends; (ii) aplunger telescopically movable within said container from a firstlocation proximate said pierceable means to a second, spaced-apartlocation; (e) adapter means for interconnecting said container meanswith said base, said adapter means comprising: (i) first hollow housingfor receiving said container of said container means, said first hollowhousing having: a. first and second open ends; b. an intermediate walldisposed between said first and second open ends; c. a sharp,needle-like hollow cannula connected to and extending through saidintermediate wall for piercing engagement with said pierceable means ofsaid container assembly; and d. a split cannula sealably closing saidfirst end of said first hollow housing; (ii) a second hollow housing forreceiving said first hollow housing, said second hollow housing beingreceivable within said receiving chamber of said base to move said splitcannula of said first hollow housing into engagement with said blunt endcannula; and (e) fluid dispensing means in communication with saidoutlet of said fluid reservoir for dispensing fluids from the device. 6.A device as defined in claim 5 further including fluid actuator meansdisposed intermediate said fluid outlet of said reservoir and said fluiddispensing means for visually indicating fluid flow from said fluidreservoir.
 7. A device as defined in claim 6 further including flowcontrol means disposed intermediate said indicator means and said outletof said fluid reservoir for controlling the rate of flow of fluid fromthe device.
 8. A device as defined in claim 7 in which said indicatormeans comprises first and second at least partially overlaying thinfilms, said films being movable relative to each other in response tofluid flowing from said fluid reservoir.
 9. A device for use in infusingmedical fluids comprising: (a) a base assembly including: (i) an ullagesubstrate having a receiving chamber formed therein; and (ii) a hollowcannula mounted within said receiving chamber; (iii) a plurality ofgenerally ring shaped guides mounted within said receiving chamber; (b)stored energy means for forming in conjunction with said base assembly afluid reservoir having an inlet in communication with said hollowcannula and an outlet, said energy storage means comprising at least onedistendable member superimposed over said base, said member beingdistendable as a result of pressure imparted by the fluids to beinfused, to establish internal stresses, said stresses tending to movesaid member toward a less distended configuration; and (c) fill meansreceivable within said receiving chamber of said base for filling saidfluid reservoir, said fill means comprising a fill assembly including acontainer and an adapter subassembly, said container beingtelescopically movable within said receiving chamber from a firstposition to a second position, said container also receivable within andguided by said ring shaped guides as said container moves from saidfirst location to said second location.
 10. A device as defined in claim9 in which said adapter subassembly comprises a hollow housing having anelongated generally cylindrical wall.
 11. A device as defined in claim10 in which said ullage substrate is provided with an elongated borehaving a longitudinally extending surface and in which said receivingchamber of said ullage substrate is defined by an elongated, generallycylindrically shaped inner wall, said inner wall defining in conjunctionwith said surface of said bore, an annular space, said wall of saidhollow housing of said adapter subassembly being telescopicallyreceivable within said annular space.
 12. A device as defined in claim11 further including fluid actuated indicator means for visuallyindicating fluid flow from said fluid outlet of said reservoir.
 13. Adevice as defined in claim 12 further including flow control meansdisposed intermediate said indicator means and said outlet of said fluidreservoir for controlling the rate of flow of fluid from the device. 14.A device as defined in claim 13 in which said indicator means comprisesfirst and second at least partially overlaying thin films, said filmsbeing movable relative to each other in response to fluid flowing fromsaid fluid reservoir.
 15. A device for use in infusing medicinal fluidinto a patient at a controlled rate comprising: (a) a reservoir assemblyincluding a base having a receiving chamber formed therein; (b) storedenergy means for forming, in conjunction with said base a fluidreservoir having an inlet and an outlet in said stored energy meanscomprising at least one distendable member superimposed over said base,said member being distendable as a result of pressure imparted by thefluids to be infused, to establish internal stresses, said stressestending to move said member toward a less distended configuration; (c)fluid delivery means in communication with said outlet of said fluidreservoir for delivery fluid from the device; (d) flow control meansdisposed intermediate said outlet of said fluid reservoir and said fluiddelivery means for controlling the rate of flow of fluid flowing fromsaid fluid delivery means; (e) closure means connected to said reservoirassembly for supporting therewithin said fluid delivery means; and (f)fill means receivable within said receiving chamber for filling saidfluid reservoir, said fill means comprising a container subassembly,said container assembly comprising: (i) a container having a fluidchamber with first and second open ends; (ii) pierceable means forsealably closing one of said first and second open ends of saidcontainer; and (iii) a plunger telescopically movable within saidcontainer from a first location proximate said pierceable means to asecond, spaced-apart location.
 16. A device as defined in claim 15 inwhich said fill means further comprises an adapter subassembly, saidadapter subassembly including a hollow housing for receiving saidcontainer, said hollow housing having first and second ends.